2种大环内酯类抗生素干混悬剂微生物限度检查方法适用性研究

Study on Applicability Validation for the Microbial Limit Test of Two Macrolide Antibiotics for Suspension

目的:建立2种大环内酯类抗生素干混悬剂的微生物限度检查方法。方法:依据《中华人民共和国药典》2020年版四部通则,采用3种薄膜过滤法对阿奇霉素和罗红霉素干混悬剂进行微生物限度方法适用性试验。结果:用含5%乙醇的pH 7.0无菌氯化钠-蛋白胨缓冲液作为稀释液和冲洗液进行薄膜过滤试验,需氧菌总数采用1∶100的供试液薄膜过滤,霉菌和酵母菌总数采用1∶10的供试液薄膜过滤,控制菌将滤膜加入100 mL培养基中,试验菌的回收率均在0.5~2,控制菌可检出。结论:所建方法能有效去除抑菌性,可用于阿奇霉素和罗红霉素干混悬剂等大环内酯类抗生素的微生物限度检查。

Objective:To establish a method of microbial limit test of two macrolide antibiotics for suspension.Methods:According to the general principles of 2020 edition of Chinese Pharmacopoeia VolumeⅣ,the applicability tests of microbial limit test of azithromycin and roxithromycin suspensions were researched by using three membrane filtration methods.Results:The pH 7.0 sterile sodium chloride peptone buffer(containing 5%ethanol)was used as the diluent and fl ushing fl uid.The membrane fi ltration method was used for the determination of the total number of aerobic bacteria(1∶100 of test solution,m/v),the total number of molds and yeasts(1∶10 of test solution,m/v),and the method with the amount of culture medium of 100 mL was used for the control of bacteria test.The recovery ratios of tested bacteria were between 0.5-2,and the specifi ed microorganism could be detected.Conclusion:The established method could eff ectively remove the bacteriostatic components and be applicable to microbial limit test for azithromycin and roxithromycin.